Fidgety Movements of Preterm Neonates Included in COSGOD III

NCT ID: NCT06105333

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-05-01

Brief Summary

The evidence on the effects of clinical care with cerebral NIRS (Near-infrared spectroscopy) monitoring on short term neurological outcome, displayed by fidgety movements between six to 20 weeks post term, are still uncertain.

Two centers (Graz and Innsbruck), who participated in the COSGOD III trial, routinely performed GMA between 37+0 to 42+0 weeks of corrected age (writhing movements) and between six to 20 weeks post term (fidgety movements).

Aim of the present study is therefore to assess in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed fidgety movements between six to 20 weeks of corrected age after discharge.

The investigators hypothesise that the preterm neonates in the intervention group of the COSGOD III trial show better survival and short term neurological outcome, displayed by normal fidgety movements, compared to neonates in the control group.

Conditions

Preterm; General Movements; Fidgety Movements; Near Infrared Spectroscopy; Neurological Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

NIRS Group

Preterm neonates less than 32 weeks gestation were randomly assigned to standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline (NIRS-group) during immediate transition (first 15 minutes after birth) and resuscitation.

standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline

Intervention Type: PROCEDURE

CrSO2 (Cerebral regional oxygen saturation) monitoring was visible to the clinical team with the same SpO2 target as in the control group. If SpO2 (oxygen saturation) remained between the 10th and 90th centiles and within local limits, and crSO2 was \<10th centile according to published reference ranges, FiO2 (fraction of inspired oxygen) was increased by 10-20% every 60 seconds or respiratory support was started or increased. If crSO2 remained \>10th centile for \>60 seconds or if rSO2 was \>90th centile,FiO2 was reduced by 10-20% or respiratory support was adjusted accordingly. If there was a history of blood loss or clinical signs of blood loss, intravenous fluids (10 mL/kg) were considered.

Standard Care Group

Preterm neonates less than 32 weeks gestation were randomly assigned to standard care (control-group) with routine monitoring during immediate transition (first 15 minutes after birth) and resuscitation.

No interventions assigned to this group

Interventions

standard care plus cerebral oxygen saturation monitoring with a dedicated treatment guideline

CrSO2 (Cerebral regional oxygen saturation) monitoring was visible to the clinical team with the same SpO2 target as in the control group. If SpO2 (oxygen saturation) remained between the 10th and 90th centiles and within local limits, and crSO2 was \<10th centile according to published reference ranges, FiO2 (fraction of inspired oxygen) was increased by 10-20% every 60 seconds or respiratory support was started or increased. If crSO2 remained \>10th centile for \>60 seconds or if rSO2 was \>90th centile,FiO2 was reduced by 10-20% or respiratory support was adjusted accordingly. If there was a history of blood loss or clinical signs of blood loss, intravenous fluids (10 mL/kg) were considered.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Preterm neonates included in the COSGOD III trial
• Death
• Routinely performed fidgety movement (FM) analysis between six to 20 weeks post term

Exclusion Criteria

• Neonates without FM analysis between six to 20 weeks post term

• Maximum Eligible Age: 40 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Pichler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Division of Neonatology, Medical University of Graz, Austria

Locations

Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Medical University of Innsbruck

Innsbruck, , Austria

Site Status: NOT_YET_RECRUITING

Countries

Austria

Central Contacts

Christina H. Wolfsberger, MD

Role: CONTACT

christina.wolfsberger@medunigraz.at

00436604422218

Gerhard Pichler, Prof

Role: CONTACT

gerhard.pichler@medunigraz.at

Facility Contacts

Christina H. Wolfsberger, MD

Role: primary

christina.wolfsberger@medunigraz.at

00436604422218

Gerhard Pichler, Prof.

Role: backup

gerhard.pichler@medunigraz.at

Ursula Kiechl-Kohlendorfer, Prof

Role: primary

Other Identifiers

Figdety Movements - COSGOD III

Identifier Type: -

Identifier Source: org_study_id